FDA.reportPublic FDA data

Carbidopa and Levodopa

Product NDC
69367-339
11-digit product format
693670339
Labeler code
69367
Product ID
69367-339_2226fb84-50af-45b1-8a9f-72984e331519
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA214092
Marketing category
ANDA
Marketing start
2021-09-30
Substance
CARBIDOPA; LEVODOPA
Active strength
25; 100 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carbidopa and Levodopa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA25 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J
Rxcui197443, 197444, 197445

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442Product name520251106
162160fe-5ea6-4f9d-aa38-c4b780c57046Product name120250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42Product name120250312
028fdaca-77da-0dfe-e445-7dfc440fc97eProduct name420250224
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name720241218
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-339-01Carbidopa and Levodopa100 in 1 BOTTLE, PLASTICTABLET1001
69367-339-05Carbidopa and Levodopa500 in 1 BOTTLE, PLASTICTABLET5001
69367-339-10Carbidopa and Levodopa1000 in 1 BOTTLE, PLASTICTABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-339CARBIDOPA AND LEVODOPA TABLET [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 3 package rows20211007_3f026272-32a6-4c98-8b6f-d910c7f58aa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN08f51366-0a54-48f5-8f10-9407458503252
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN0215da3f-13a0-400d-ac2d-20c839bd89ef2
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD08f51366-0a54-48f5-8f10-9407458503252
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD0215da3f-13a0-400d-ac2d-20c839bd89ef2
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY08f51366-0a54-48f5-8f10-9407458503252
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY08f51366-0a54-48f5-8f10-9407458503252
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY0215da3f-13a0-400d-ac2d-20c839bd89ef2
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN3f026272-32a6-4c98-8b6f-d910c7f58aa21
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN3f026272-32a6-4c98-8b6f-d910c7f58aa21
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN3f026272-32a6-4c98-8b6f-d910c7f58aa21
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD3f026272-32a6-4c98-8b6f-d910c7f58aa21
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD3f026272-32a6-4c98-8b6f-d910c7f58aa21
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD3f026272-32a6-4c98-8b6f-d910c7f58aa21
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY3f026272-32a6-4c98-8b6f-d910c7f58aa21
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY3f026272-32a6-4c98-8b6f-d910c7f58aa21
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY3f026272-32a6-4c98-8b6f-d910c7f58aa21
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY3f026272-32a6-4c98-8b6f-d910c7f58aa21
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY3f026272-32a6-4c98-8b6f-d910c7f58aa21
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY3f026272-32a6-4c98-8b6f-d910c7f58aa21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-339-0169367033901100 TABLET in 1 BOTTLE, PLASTIC (69367-339-01) 100 tablet2021-09-300000-00-00NoNoCurrent
69367-339-0569367033905500 TABLET in 1 BOTTLE, PLASTIC (69367-339-05) 500 tablet2021-09-300000-00-00NoNoCurrent
69367-339-10693670339101000 TABLET in 1 BOTTLE, PLASTIC (69367-339-10) 1000 tablet2021-09-300000-00-00NoNoCurrent